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FDA 510(k)

Lyme B. burgdorferi (IgM) MarStripe Test

K-Number: K172254 · 2017-10-23

ApplicantTrinity Biotech
Decision Date2017-10-23
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Lyme B. burgdorferi (IgM) MarStripe Test is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K172254. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lyme B. burgdorferi (IgM) MarStripe Test?

Lyme B. burgdorferi (IgM) MarStripe Test is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Trinity Biotech. The 510(k) number is K172254.

When did Lyme B. burgdorferi (IgM) MarStripe Test receive FDA 510(k) clearance?

Lyme B. burgdorferi (IgM) MarStripe Test received FDA 510(k) clearance on 2017-10-23, under 510(k) number K172254.

Who is the listed applicant for Lyme B. burgdorferi (IgM) MarStripe Test?

The FDA 510(k) record lists Trinity Biotech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lyme B. burgdorferi (IgM) MarStripe Test?

The FDA product code for Lyme B. burgdorferi (IgM) MarStripe Test is LSR.

Other records listing Trinity Biotech as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163095Lyme B. burgdorferi (IgG) MarStripe Test

Related Devices (Code: LSR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificK220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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